Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Musculoskeletal Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Osteosarcoma

Neoplasm Metastasis

Lung Neoplasms

Multiple Myeloma

Neoplasms, Plasma Cell

Cancer Pain

Pain

Bone Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neoplastic Processes

ExAblate MRfFUS

Sham

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy

ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy

Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), each subject was rated as a Responder or Non-responder. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use.

Medication Use change reported from baseline until of study. Medication use is quantified by "morphine equivalent usage" (measured separately from Responder/Non-responder definition for the primary endpoint)

The BPI-QOL questionnaire is designed to show the severity and interference of pain in the lives of patients. This is a 7-item questionnaire that asks respondents the extent to which pain interferes with their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life using a 0-10 numerical rating scale in which 0 represents 'does not interfere' and 10 indicates 'completely interferes'. Responses to the 7 items are averaged to form the pain interference scale score. Lower scores are better, showing less interference in daily activities while higher scores show more interference and hence worse outcomes.

InSightec

ExAblate 2000: MR guided focused ultrasound

ExAblate Treatment Arm

ExAblate 2000: MR guided focused ultrasound sham

ExAblate Sham Control Arm

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Canada

United States

Italy

Israel

Russia

Region of Enrollment

Nadir Alikacem

115 subjects were underwent treatment. Of these, 4 subjects terminated treatment prior to full completion. These 4 subjects are excluded from the efficacy analysis. An additional 4 subjects were found to have been enrolled in the study more than once. In a pre-PMA meeting with FDA, it was agreed upon to exclude these 4 subjects from the analysis.

Number of Responders

Only 26 of the 81 subjects in ExAblate treatment arm and 6 of 26 in the sham arm were taking non-opioid medication at baseline.

Number of Participants With a Change in Medication Use

Quality of Life (QOL) as Measured by Change in Bodily Pain Inventory (BPI) From Baseline

Overall Study

Spots Global Cancer Trial Database for ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial